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Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. J Am Coll Cardiol. Warnings Do not use kinked or damaged devices. The Indigo Aspiration System is contraindicated in: Otherwise, this could result in degradation of the performance of this equipment. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. BJC Cardiology The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. This content is not intended to offer professional medical advice. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Do not use in oxygen rich environment. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. The pulmonary capillary wedge pressure is 10 mmHg. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Indication For Use The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Flow through left circumflex artery post-CAT RX. Contraindications There are no contraindications. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. The CAT family of catheters is the foundation of Penumbra's Indigo System. Initial angiogram showing high thrombus burden in the RCA. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . Do not re-infuse blood or fluid from the canister back into the patient. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. 0, and 37. Potential Adverse Events Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. These types of burns heal withing 5 or 6 days without permanent scarring. Distal emboli causing PDA occlusion after manual aspiration. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. If the cause cannot be determined, withdraw the device or system as a unit. The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Disclosures: None. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Figure 1. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. If the cause cannot be determined, withdraw the device or system as a unit. 2019;140:e774-e801. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Warnings/Precautions The canister is intended for single use only. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Prior to use, please consult device labeling and instructions for use. The Indigo Separator 4 is not intended for use as a guidewire. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Possible complications include, but are not limited to, the following: Final angiographic result of SVG. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Equipment is not safe for MR use. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Do not re-infuse blood or fluid from the canister back into the patient. Not for use in the coronaries or the neurovasculature. Equipment is not safe for MR use. Warnings Suhail Dohad, MD, FACC Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The CAT family of catheters is the foundation of Penumbra's Indigo system. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Return all damaged devices and packaging to the manufacturer/distributor. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The product-specific content of this website is intended for use by healthcare professionals only. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Order Qty. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Figure 1. These pages are not intended for patients or for members of the general public. Do not use kinked or damaged devices. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Precautions PENUMBRA ENGINE Indication for Use gtag('js', new Date()); The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Disclosures: None. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). 1. Jawairia Sahar K. Mirza, MBBS To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Indigo Aspiration System Intended Use CAT RX has allowed us to rethink how we approach these occluded SVGs. She had acute tubular necrosis with minimal urine output at the time of transfer. Contraindications There are no known contraindications. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 2018;72:1589-1596. Vascular Thrombectomy. INDIGO Aspiration Catheters and Separators: If the cause cannot be determined, withdraw the device or system as a unit. Brandenton, Florida CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Interventional Cardiology The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Maintain a constant infusion of appropriate flush solution. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use in an oxygen rich environment. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 2015;372:1389-1398. window.dataLayer = window.dataLayer || []; Do not block bottom air vents. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . The patient remained on cangrelor with no need for tirofiban. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; Enter your email address and we will contact you. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Device Name. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Contraindications The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Worcester, Massachusetts Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. The cerebral vasculature The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The CAT family of catheters is the foundation of Penumbra's Indigo System. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The device is intended for single use only. Do not use open or damaged packages. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Do not reuse. The INDIGO SEPARATOR is not intended for use as a guidewire. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 510 (k) Number. Figure 3. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Copyright 2022 Penumbra, Inc. All rights reserved. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. It will reduce service life of the Penumbra ENGINE. Separator 8, 150 cm Length, 0.072 in. The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. Learn more about Lightning. gtag('js', new Date()); With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. The procedure can be performed quickly,1 which is important for symptomatic patients. gtag('js', new Date()); It will reduce the service life of the PENUMBRA ENGINE. Contraindications Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Final angiogram showing resolution of extensive thrombus burden. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Giri J, Sista AK, Weinberg J, et al. LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Potential Adverse Events Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. 0, 26. Use prior to the Use By date. Distal posterior tibial artery emboli occlusion. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. 1. To prevent fire or shock hazard, use a replacement power cord of equal rating. Tareq Kass-Hout. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Units in stock: 1. Contraindications Not for use in the coronaries or the neurovasculature. allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The CAT familyof catheters is the foundation of Penumbras Indigo System. Figure 2. Maintain a constant infusion of appropriate flush solution. The pain became more intense and constant, so he presented to the ED. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). UMassMemorial University Campus Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The complaint has been evaluated. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. suhail.dohad@cshs.org Conclusions: evaluation of the cat8 revealed that the device was fractured. Mathews SJ, Brown C, Kolski B, et al. Final angiogram after stent placement showing resolution of underlying disease. Latest System Designed for Single Session Arterial Thrombus Removal News The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure.